ImagenQ

GUDID 00862611000325

The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00862611000325
NIH Device Record Key856bae61-5c1a-4745-a4b4-454e2b1a7c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagenQ
Version Model NumberV2.0
Company DUNS626962596
Company NameCARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100862611000325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2018-02-21

Devices Manufactured by CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

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00862611000318 - ImagenPRO2019-10-07 ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspec
00862611000325 - ImagenQ2019-10-07The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
00862611000325 - ImagenQ2019-10-07 The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating
00862611000332 - ImagenUniversal2019-10-07 ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET
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